Background
Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery replaces Directive 2006/42/EC on machinery. The regulation - as did the 2006 directive - defines the mandatory essential health and safety requirements that machinery products must fulfil to be placed on the European market, as well as the procedures for assessing their conformity, while the technical details are mainly provided through European harmonised standards elaborated by European standards organisations. The requirements of the Regulation are aimed at machinery manufacturers and other economic operators such as importers. The CE marking indicates that the machinery product meets the health and safety requirements in place and can be traded without restriction in the internal market.
In comparison with the 2006 Directive, the Regulation clarifies some complex issues such as 'incomplete machinery' and 'substantial modifications'. The Machinery Regulation also intends to better cover new technologies such as autonomous mobile machinery (robots), internet of things with connected equipment, or artificial intelligence (AI), where specific modules of AI using learning techniques ensure safety functions.
Since these requirements for machinery are laid down in the form of a Regulation, they are directly applicable in Member States as, unlike those of a Directive, there is no need for them to be transposed into national legislation.
Objective
The objective of the Machinery Regulation is to allow that machinery, related products as well as partly completed machinery are made available on the market while ensuring a high level of protection of the health and safety of persons, in particular consumers and professional users.
Definitions
The Regulation defines terms such as "machinery", "interchangeable equipment", " safety component", " safety function", " substantial modification", "placing on the market", "manufacturer", " CE marking", " instructions for use", etc.
Scope
The Regulation applies to machinery and related products:
- interchangeable equipment;
- safety components;
- lifting accessories;
- chains, ropes and webbing;
- removable mechanical transmission devices.
And, also to partly completed machinery.
Several types of equipment are excluded from the scope of the Regulation such as motor vehicles and their trailers, specific equipment used in fairgrounds or amusement parks or machinery specially designed and constructed for research purposes for temporary use in laboratories.
Contents
Machinery or related products may be made available on the market or put into service only if, when properly installed and maintained and used for their intended use or under conditions which can reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III. Partly completed machinery may be made available on the market only if it meets the relevant essential health and safety requirements set out in Annex III.
When placing machinery or a related product on the market or putting it into service, manufacturers have to ensure that it has been designed and constructed in accordance with the essential health and safety requirements. They also have the responsibility to draw up the technical documentation and to carry out the relevant conformity assessment procedure. Machinery and related products (‘high risk machinery products’) are subject to third party conformity assessment procedures.
Where compliance of machinery or a related product with the essential health and safety requirements has been demonstrated by the relevant conformity assessment procedure, manufacturers shall draw up the EU declaration of conformity and affix the CE marking. Manufacturers also have to ensure that the machinery or related products are accompanied by the instructions for use that can be easily understood by users. These instructions may be provided in a digital format.
The Regulation also includes requirements for national authorities responsible for conformity assessment bodies (notified bodies). The EU Commission publishes a list of bodies notified under this Regulation including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified.
The Regulation applies from 20 January 2027. However, some rules already apply on earlier dates such as the requirements for notified bodies (14 January 2024).
Annexes
- Annex I Categories of machinery or related products to which one of the procedures referred to in article 25(2) and (3) shall be applied
- Annex II Indicative list of safety components
- Annex III Essential health and safety requirements relating to the design and construction of machinery or related products
- Annex IV Technical documentation
- Annex V EU Declaration of conformity and EU Declaration of incorporation
- Annex VI Internal production control
- Annex VII EU Type-examination
- Annex VIII Conformity to type based on internal production control
- Annex IX Conformity based on full quality assurance
- Annex X Conformity based on unit verification
- Annex XI Assembly instructions for partly completed machinery
- Annex XII Correlation table with Directive 2006/42/EC
Read the full text of Regulation 2023/1230 on Machinery
Further information
EU Commission DG Internal Market, Industry, Entrepreneurship and SMEs Machinery